Page 24 - BSI Training Brochure 2021
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Medical Devices
In Vitro Diagnostic Regulation Specialist training
IVD Directive to IVD Regulation (IVDR) Medical Device Single Audit Program Technical Documentation for In Vitro
Transition training course (MDSAP): Fundamentals and Readiness Diagnostic Devices*
There are significant changes in the European This course will prepare you to host a MDSAP audit Technical documentation includes the collation
legislation applicable to IVDs. The IVDR (In Vitro and allow you to determine if your own internal of supporting information about your IVD Device
Diagnostic Regulation) (EU 2017/746) has replaced QMS processes are consistent with the and is a required part of conformity assessments
the IVD Directive (98/79/EC), and will impose new requirements of the MDSAP audit mode for the and CE Marking. This course enables greater
requirements on manufacturers and other jurisdictions where your products are marketed. understanding of the key requirements for
Economic Operators. Our one day training course technical documentation for IVDs, in line with the
has been designed to introduce IVD manufacturers Duration 2 days IVDR requirements in Europe. Learn how to
and other Economic Operators in the supply chain assemble this and other types of required
to the key changes to requirements for CE marking information so you can CE Mark your device
following the publication of the new IVD in Europe.
Regulation (IVDR).
Duration 1 day
Duration 1 day
Requirements of the In Vitro Diagnostic Implementation of the In Vitro Performance Evaluation and Clinical CE Marking with Software
Regulation Training Course Diagnostic Device Regulation for CE Evidence for In Vitro Diagnostic Devices This course will help you understand how
Marking Training Course
Learn about the key requirements of the new In This course will enable a greater understanding of directives apply to your organizations’ software,
Vitro Diagnostic Regulation (IVDR EU 2017/746), To help implement the requirements of the performance evaluation for IVD Devices under the how software is classified and how to achieve and
published in Spring 2017 with a five year transition European In Vitro Diagnostic Device Regulation IVDR, looking at how this performance fits into the maintain a CE mark. Learn the steps to define,
period. The Regulation will affect all In Vitro (IVDR 2017/746) to obtain and maintain the CE product development lifecycle and IVDR classify, develop and test your medical device
Diagnostic device manufacturers, importers, mark for your product. Gain confidence with the requirements for clinical evidence. software, which is important to keeping your
distributors and EU Representatives. IVD classification rules and the conformity Duration 1 day product marketable.
assessment routes.
Duration 1 day Duration 1 day
Duration 3 days
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